[BobbyB]

Research into lithium offers new hope for PALS
Leo Greene, Staff Writer
Article Launched: 01/26/2008 07:03:45 PM PST


Editor's note: Daily Bulletin reporter and videographer Leo Greene has been documenting his journey since being diagnosed with ALS, Lou Gehrig's disease, in August 2006.
Italian researchers claim to have stopped ALS dead in its tracks.

By stopped, they mean no progression.

By ALS, we mean the incurable disease for which there has been no significant medical breakthrough.

The Proceedings of the National Academy of Sciences, no slouch as scientific journals go, has accepted the researchers' paper for publication. We should see the details of their possibly landmark study in early February, a journal spokeswoman said.

I want to avoid overstating the significance of these findings from what is, after all, only a single, small clinical trial.

But on its face, it's significant.

Sixteen ALS patients were given two drugs: Riluzole, the generic name for the only drug approved for treating ALS, and lithium, a mood stabilizer used for bipolar disorder and depression.

Another 32 patients took only the Riluzole.

The patients - 16 on lithium and 32 not - were watched and evaluated over a period of 15 months.

The results of the trial were announced in early November at a Parkinson's disease conference in Italy. News of the findings was carried in an Italian science journal.

At the end of the 15 months, 30 percent of the group not taking lithium had died. Those who remained suffered on

average 50 percent decline.
This is what one would expect with ALS.

For those taking lithium, however, there were no deaths. Additionally, the ALS patients taking lithium experienced no meaningful disease progression, according to Francesco Fornai of the University of Pisa.

Two years after starting on lithium, only two had died, one from a heart attack and the other, who suffered from an advanced, aggressive case to begin with, from ALS-related causes.

The rest remained stable with no progression.

"Two years of nonprogression, that would be dramatic and unheard-of," said Dr. Laura Nist, chief of the Loma Linda University Medical Center ALS Clinic.

Nist remained skeptical, however, noting that the trial was small and details on the methodology have yet to be made public.

"I want to be encouraged. But right now I have more questions than answers," she said.

Since the dramatic findings were announced back in November, news has spread. PALS - People with ALS - around the globe have been asking their physicians for lithium.

I first heard about the trial from Alan Felzer, a retired Cal Poly professor and Claremont resident diagnosed with ALS in August 2007, a year after my diagnosis.

After getting the news about his condition, Alan and his wife, Laura, sought out second and third opinions from specialists in San Diego, San Francisco and Loma Linda. Someone out there on the cutting edge had to be close to a cure.

Alan is a self-described optimist.

"When I first got it, I figured this is going to be like one of those things on TV - the Lone Ranger - where everybody in the last two minutes gets saved," he said.

But none of the doctors were brandishing six shooters or dispensing lifesaving solutions.

As an electrical-engineering professor with grounding in science, Alan knew how to conduct his own research. He scoured the Internet along with his science-savvy daughter.

Karen Felzer, with a Harvard doctorate, investigates the causes of aftershocks as a USGS earthquake seismologist based at Caltech. She also makes occasional after-quake appearances on local and national TV news shows.

The father-daughter Internet searches developed a sense of urgency. Alan's illness seemed to be progressing faster than average.

Back in August, Alan experienced some difficulty walking. "But it wasn't anything that serious," Karen said.

Now, he requires a walker or a wheelchair, and he's losing strength in his arms.

One day in December, Karen put her infant son down for a nap and decided to make an all-out assault on the Internet, clicking on every link that came up like rabbits in a carnival shooting gallery.

"I saw this link that said lithium plus Rilutek, and I didn't think much of it," she said.

This rabbit, however, led her to a whole new place.

Karen was used to reading studies where successes were tallied, usually with laboratory mice, in marginally better outcomes. The Italian study was different.

"To have 16 people not progress, I'd never seen anything like that before," she said.

Alan got his doctor to prescribe lithium at a dose matching the Italian trial. He took his first pill on Jan. 4.

In the Internet forums where people share information about ALS, Karen found others starting on lithium. She joined forces with a man in Brazil who had developed a spreadsheet to keep track of PALS on lithium.

Humberto Macedo is a 41-year-old PALS, computer systems expert and family man.

Together, Karen and Humberto are running their own international clinical trial.

"Today we're 30 PALS worldwide on a spreadsheet," Humberto said via e-mail. "Hopefully we'll be 50 soon."

My name is on that sheet. I took my first pill Jan. 17.

Dr. Nist offered one admonishment for those planning to give lithium a try: Do it under a doctor's supervision. Lithium can be used safely but only with constant monitoring.

Karen and Humberto agree. Their trial requires participants to submit the results of regular blood tests.

Now, we monitor, watch and wait.

Humberto calls lithium "the first real hope."

It could buy us time until better treatments, even restorative treatments, are developed.

For Alan, the results of the Italian study provide "every reason not to hesitate. I'm optimistic."

And if in the end things haven't worked out quite the way we had wanted, "We won't be sad," said Humberto.

No, my friend. The taste of hope is sweet, even if it's only for a short time.

We won't be sad.

Karen Felzer's trial Web site can be accessed at http://alslithium.atspace.com/index.html.

http://www.sbsun.com:80/news/ci_8088813

[BobbyB]

ALS MND LITHIUM INFORMATION AND RESEARCH SITE

In November of 2007, researchers in Italy announced the results of a trial using Lithium Carbonate to treat 16 ALS patients, in which they claimed that no patients progressed over the 15 month trial period. This study has yet to be published, but, if the results are verified, they are unprecedented in ALS research. In fact, previous laboratory studies have demonstrated that lithium has numerous neuro-protective properties.

This website has been created to help spread information about lithium for treatment of ALS, and to gather data from ALS patients choosing to try or not to try lithium treatments in an attempt to verify the results of the Italian study.


Warning! Lithium in any form can be toxic. Lithium should not be taken without a doctor's supervision and frequent monitoring of blood levels.


Update 1/27/08- We have received word that the Italian study has been accepted for publication by the Proceedings of the National Academy of Sciences and will be published in February.




The Italian Study
Our Analysis of the Study Results
Will Lithium Treatment Work for All PALS?

Lithium Dosage
Health Precautions
Why Lithium Might Work to Slow Progression of ALS; laboratory research
Previous Encouraging Lithium Studies on People
Delay in Lithium Efficacy
Drugs, Supplements, and Foods that Interact with Lithium
Lithium Alternatives
References

**Please Participate in Our Lithium Study**

Our Study: This week's graph

Tracking Patients: Our current spreadsheet

Who we are

External links:
ALS TDI Lithium Discussion Forum
ALS TDI Lithium Survey
Leo Greene's Column on our Lithium Study

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Last updated January 29, 2008